2. Rev.1 07/2015
NB-SAK-IFU-001
Sinus Elevator
SCA
Kit
SLA
Kit
+ +
Surgical
Kit
Neo SinusAll Kit
This product is a SinusAll Kit, consisting of dental implant surgical tools (drills, surgical tools,
and drivers) made out of medical grade materials, including stainless steel.
Product description
The SinusAll Kit combines NeoBiotech’s SCA (Sinus Crestal Approach) Kit, SLA (Sinus
Lateral Approach) Kit, and the Surgical Kit into a single kit. The product allows maxillary sinus
implant procedures to take place using a single kit, rather than having to prepare a sinus kit
and a surgical kit separately.
Intended use
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Ø2.0 Ø4.0Ø3.7Ø3.2Ø2.8
12.0
11.0
10.0
9.0
8.0
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0
0.2
Ø2.8 Ø3.9Ø3.6Ø3.2
Store at room temperature in a dry location away from direct light.
Preservation
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2
3
4
Prior to using this product, the clinician must completely understand the condition, perfor-
mance, and function of the product.
Use only after raising any doubts and verifying any issues with the manufacturer.
For the procedure, a plan must be first established, based on checking the patient’s oral
condition and accurate judgments.
After taking into consideration the condition of the patient, tools appropriate for the proce-
dure must be prepared.
How to Prepare Before Use
<Crestal Approach Tool Components>
Components
Surgical Drill1
Consist of a total of five types :
Ø2.2 / Ø2.8 / Ø3.2 / Ø3.7 / Ø4.0
Ensure safe drilling by attaching a stopper.
Drill 1 mm shorter than the remaining
maxillary sinus bone.
S-Reamer2
Consist of a total of four types :
Ø2.8 / Ø3.2 / Ø3.6 / Ø3.9
Ensure safe drilling by attaching a stopper.
* 1,200rpm
Diameter(Ø) Product Name
Ø2.2 SAD22
Ø2.8 SAD28
Ø3.2 SAD32
Ø3.7 SAD37
Ø4.0 SAD40
* 1,200rpm
Diameter(Ø) Product Name
Ø2.8 SAR28
Ø3.2 SAR32
Ø3.6 SAR36
Ø3.9 SAR39
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The reamer does not hurt the membrane because
during drilling, the bone chip filled the reamer space
so it makes more wide and safe side
Creates a hole of the desired size in the sinus inferior cortical wall without damaging the
sinus mucosa.
Even direct contact with the tool does not cause the sinus membrane to rip. Accordingly,
the membrane is safe even when drilling through the side or the septum.
Bone chips are formed by the end of the S-Reamer’s blade in a flat shape, meaning
that the membrane will not rip, even if there is direct contact with the sinus membrane
Misaligned case Septum
Ø2.8 Ø3.9Ø3.6Ø3.2
Rotary elevator
Head
Bone
Disk
Rotary elevator3
This tool is used to initially remove the mesial and distal membranes immediately after a
hole is formed.
This tool is used to push the bone into the interior and the sides of the sinus after the
bone is inserted into the hole.
* 80rpm
Diameter(Ø) Product Name
Ø2.8 SARE28
Ø3.2 SARE32
Ø3.6 SARE36
Ø3.9 SARE39
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Stopper4
Consist of a total of twelve types, from 1 to 12 mm
Used by attaching to a Drill, S-Reamer, Depth
gauge, Bone Condenser, or other tool.
The various stoppers have different colors to prevent
confusion.
When a stopper is attached to a drill, the drill
becomes 0.2 mm longer.
Length
0.2mm
Insert slowly, hugging the wall closely with the tip part.
With both sides of the tip flat, the tip is designed to hook inside
the sinus wall.
Care must be taken not to insert the depth gauge more than 1mm
further than the length of the remaining bone.
Ø2.6
Ø3.1
1 2 3 4 5 6 7 8 9 10 11 12
Bone carrier6
Product Name
SADG01
Product Name
JUMB02
Length 1mm 2mm 3mm 4mm 5mm 6mm 7mm 8mm 9mm 10mm 11mm 12mm
CDS010 CDS020 CDS030 CDS040 CDS050 CDS060 CDS070 CDS080 CDS090 CDS100 CDS110 CDS120Product
Name
Depth gauge5
Tip sizes come in Ø2.6 and Ø3.1
This tool is used to measure the
thickness of the remaining bone.
The depth can be safely verified
when a stopper is attached.
This tool is used to transplant insert the bone inside a sinus hole.
Volume inserted per use: 0.05 cc
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Bone condenser7
8-1) Aqua Tap 8-2) Aqua Valve, Hose, Syringe
Syringe
Auqa Value
Hose
<How to Use>
1. After completing drilling towards the Crestal direction, self-tap the
Aqua Tap using a Torque Ratchet for fixation to the bone.
2. Insert the blue rubber part of the Aqua System valve into the head
hole of the Aqua Tap, fixing it.
3. Fill the syringe with the desired amount of physiological saline solution,
then inject slowly.
Product Name
SABC01
Product Name
AQT
Product Name
AQST
Aqua system8
This is a system for detaching sinus membrane that uses water.
Its design is based on a 3 cc syringe; the extent of detachment can be adjusted.
This tool is attached to the bone after a si-
nus hole has been formed in order to allow
water to be safely injected into the sinus.
This tool detaches sinus membrane using
the water inside the syringe.
A set of this tool consists of an aqua
valve, a hose, and a syringe.
Ø1.0
Ø2.2
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Rotary elevator
S-reamer
This tool is connected to contra angle type devices, such as a drill or Rotary Elevator, in
order to allow the user to utilize them manually.
Drill Handle9
Product Name
SADH01
9-1) Use as Osteotome
9-2) Use by connecting to a Rotary Elevator or S-Reamer
Possible to use as an osteotome, by connecting a surgical drill to the Drill Handle.
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C-guide C-reamer
* 2,000rpm(20:1) / 5,000rpm(1:1)
Ø6.5
Ø6.5 Ø6.5
The C-Reamer is a drill used to create a circular core while forming a bone window in
the lateral wall.
Can be used to drill safely by attaching a stopper.
<Special Characteristics and How to Use>
* 2,000rpm(20:1)
5,000rpm(1:1)
<Lateral Approach Tool Components>
LS-Reamer1
This tool forms a thin bone disk between the reamer and the membrane during lateral
approach and penetrates the lateral wall.
There is a single size—Ø6.5. This tool can be used to drill safely by connecting a Lateral
Stopper.
C-Guide & C-Reamer2
The C-Guide is a guide drill used to prevent slippage and to locate the position ac
curately before use of the C-Reamer.
1. With adequate irrigation, can be used to drill at 2,000 to 5,000 rpm.
2. When creating a lateral hole, prevents sinus membrane damage by forming a thin bone
disk between the sinus membrane and the LS-Reamer.
3. Helps perform the procedure safely by allowing visual observation of the hole as it is
formed, allowing visual identification of special anatomical features, such as blood ves
sels or the septum, in the course of drilling.
Product Name
SALS640
Product Name
SACG610
Product Name
SAC640
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Ø3.0
A B
* 1,200rpm
<Window extend>
<Special Characteristics and How to Use >
1. The circular core that is formed by drilling will be 1 mm smaller than the head size of the
C-Reamer. This can be detached from the membrane and stored to be used as a
cover after the procedure.
2. The cutting edges of the C-Reamer are formed on the front and the side, allowing fast
drilling at 2,000 rpm or higher. Sinus membrane damage is minimized because bone
chips are discharged around the cutting edges.
(Because the core tends to become wedged inside the head of the C-Reamer and
spin in place, it is recommended that, after an appropriate amount of drilling, the user
remove the core before it is completely formed, using an Elevator)
This tool is used to initially remove the mesial and the distal membranes immediately after
formation of the hole.
Sinus Elevator3
3-1) Elevator 1
This tool is used to initially remove the mesial and the distal membranes immediately after
formation of the hole.
3-3) Elevator 3
This tool is used to detach any remaining tissue from the deep interior parts.
3-2) Elevator 2
This tool is used after Elevator 1. The hook is used to detach the lower part of the lateral
wall from the hole.
The part with a gentle slant of approximately 30° is used to remove the membranes from
the entire sinus floor and from the medial and posterior walls.
Product Name
SLE01
Product Name
SLE02
Product Name
SLE03
Product Name
SCT30
Side cutter4
This tool is used laterally to widen a hole formed using the LS-Reamer or the C-Reamer.
It comes in one size : Ø3.0
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NB-SAK-IFU-001
A : 0.7mm
A : Stopper Length
B : Length
C : 1.5mm
Short Long
Lateral stopper5
Consist of a total of four sizes: 1 to 4 mm
Use after connecting to the LS-Reamer,
C-Reamer, Side Cutter, or other
components.
When a stopper is connected to the LS-
Reamer or the C-Reamer, those tools will
be lengthened by 0.7 mm.
When a stopper is attached to the Side
Cutter, the latter tool will be lengthened
by 1.5 mm.
Length 1mm 2mm 3mm 4mm
LTS010 LTS020 LTS030 LTS040Product
Name
<Implant Placement Tool Components>
Fixture driver1
This tool is used to implant the fixture
It includes two types of ratchets and one type of contra angle.
Length Product name
Ratchet (Short) ISFD10R
Ratchet (Long) ISFD15R
Contra Angle ISFD05C
Product name
HD1215S
Product name
TW60
This tool is used to connect the cover screw, Healing Abutment, Abutment screw, and
other components to the implant.
Hex driver2
This tool is used by connecting to a type of ratchet when emplanting or applying torque
to an implant.
Torque wrench3
15mm
Hex 1.2
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How to Sterilize
In order to effectively carry out high-pressure steam sterilization, the use of biological indicators at a regular
interval must be considered. (Dry heat sterilization or chemical sterilization is not recommended.)
① Minimum time and temperature conditions for steam sterilization to reach the sterilization guarantee level
of 10
-6
② If regional or national sterilization requirements are stricter than the conditions provided above, they must
be followed.
If the above sterilization conditions are exceeded, it is possible that the plastic and components may be
damaged. The sterilization device must be adjusted to ensure that the recommended temperatures are
not exceeded.
Cycle Type Temperature Pressure Dry Time
KIT,
Instrument
Pre-vacuum¹²
132 ℃ 2 bars
3 minutes 30 minutes
270 °F 28.5 psi
KIT,
Instrument
Gravity¹
121 ℃ 1 bars
40 minutes 30 minutes
250 °F 14.5 psi
Exposure
Time
<Recommended Steam Sterilization Conditions >
Because the product is a non-sterilized medical device, select either a pre-vacuum or a
gravity autoclave. (Plastic products must not be sterilized at or above 170°C (338°F)
Before sterilization, the inner wrapper must be removed from the tray. Assembled compo-
nents must be separated in order to improve the efficiency of sterilization.
Using surgical wrap, wrap the tray, seal with autoclave tape, and sterilize.
1
2
3
Surgical Tools
1
2
3
4
After the procedure ends, detach all surgical tools from the tray, soak them in alcohol, and
rinse them using conventional means.
After washing by using distilled water or flowing water and rinsing, remove any traces of
blood or foreign objects remaining. Use a syringe or pipe cleaner for areas that are difficult
to wash.
Following the instructions of the cleaner manufacturer, dilute the enzyme cleaner using
tap water and, after ten minutes of ultrasound washing, rinse using tap water for three
minutes.
Completely remove the moisture using a dry cloth or a warm-air circulator.
KIT Tray
1
2
3
Remove all visible foreign objects using distilled water or flowing water and a soft brush. For
areas that are difficult to clean, use a syringe or pipe cleaner.
Following the instructions of the cleaner manufacturer, dilute the enzyme cleaner using tap
water and soak for one minute. Afterwards, using a soft brush, remove any foreign objects
remaining on any part.
After washing, rinse for three minutes using tap water to remove the remaining enzyme
cleaner.
How to Wash after Use
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4
5
Completely remove the moisture using a dry cloth or a warm-air circulator.
Organize the dry surgical tools in the kit case and sterilize, following the sterilization proce-
dure. (At this time, refer to the colors to make the setup easy.)
1
2
3
All surgical tools that were used must be immediately detached, washed, and dried, after
the procedure, then stored at room temperature.
Do not store in a soiled area or where there is a risk of infection.
This product is a non-sterilized medical device. Accordingly, it may be used only after
sterilizing in an autoclave before and after any procedure. (See How to Sterilize)
How to Store and Maintain after Use
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2
3
4
5
6
7
Only dentists who have completed implant procedure education and training courses can
use this product.
For each patient, a procedure plan must be established, based on a treatment plan after
testing and analyzing for whole-body ailments, infectious disease, whether they are receiv-
ing treatment for other ailments, and whether there is any oral lesion.
The surgeon must use the product only after becoming completely familiar with how to
use the product and the relevant warnings, and must select products that fit the treat-
ment plan.
Before each procedure, the tools must be examined for wear and tear.
Any external contact with the surfaces is prohibited.
Improper selection of the patient or procedure may cause failure of the implant or post-
surgical bone loss around the implant.
Hydrogen peroxide is prohibited for disinfection and washing, as it could damage or dis-
color the TIN coating, laser markings, or colors.
Precaution
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2
3
4
5
6
7
Patients with serious internal ailments: endocrinal ailments such as diabetes or hyperten-
sion, circulatory ailments, and ailments related to the blood, organ, or immune systems.
Patients receiving high-level radiation treatment for malignant tumors or other reasons.
Patients who have unsuitable jaw relations or problematic occlusions.
Patients with dry mouths.
Patients with unrestored teeth who maintain bad oral health conditions.
Patients with acute inflammatory ailments and patients who are at risk of infection.
Pregnant patients.
Contraindication
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11
12
13
14
15
16
8
10
9
Smokers.
Patients with blood clotting conditions or with severe cardiac ailments.
Children aged 16 years or younger.
Patients who are allergic to titanium or stainless steel.
Patients without ordinary wound-healing function.
Patients who are taking other drugs.
Patients who are vulnerable to physical and mental stress due to temporary use of a spe-
cific medication.
Patients who are emotionally unstable, such as due to alcohol addition, drug abuse, neuro-
logical ailments, or mental ailments.
Patients who have unrealistic expectations regarding the treatment.
1
2
3
Using surgical techniques in a skillful manner minimizes the occurrence of complications.
Paresthesia due to nerve damage or malocclusion, infection, edema, hypodermic bleed-
ing, pain, or opening of the sutures, ulcer in the soft tissues, and other localized adverse
reactions may occur.
Localized and general allergic reactions.
Side effect
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* This product is a non-sterilized medical device.
Label Symbols
Symbol Definition Symbol Definition
Catalog Number
Consult instruction
for use
Batch Code
Sterilized Using
irradiation
Date of manufacture Prescription Only
Manufacturer Do not re-use
Caution, consult
accompanying
documents
Do not use if
package is damaged
Non-Sterile
